NCT06546020 · Montana State University
Gut Microbiota-dependent Health Impacts of Haskap Berries
(HIH)
What this study is about
Polyphenol-rich Haskap berries (Haskap) have untapped therapeutic potential to improve human health, and agricultural producers in northern U.S. states are poised to increase production if consumer demand increases. A critical knowledge gap is that little is known about the interactions between gut microbes and Haskap polyphenols to produce bioactive metabolites linked to downstream health impacts.
View original scientific description
Polyphenol-rich Haskap berries (Haskap) have untapped therapeutic potential to improve human health, and agricultural producers in northern U.S. states are poised to increase production if consumer demand increases. A critical knowledge gap is that little is known about the interactions between gut microbes and Haskap polyphenols to produce bioactive metabolites linked to downstream health impacts. Additionally, little is known about which Haskap varieties and harvest timing yield the greatest bioactive potential. This study aims to address these gaps by investigating the interaction of bioactive components in Haskap with gut microbiota and the resultant gut and serum metabolites, inflammation, and metabolic health, and then couple this with analysis of berries from different Haskap varieties and harvest times.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for Metabolically Healthy Group: All of the following:
- Waist circumference: men ≤ 40, women ≤ 35 inches
- Systolic blood pressure: ≤ 130 mmHg
- Diastolic blood pressure: ≤ 85 mmHg
- Fasting glucose: ≤ 100 mg·dl-1
- Fasting triglycerides: ≤ 150 mg·dl-1
- HDL: men \> 40, women \> 50 mg·dl-1 Inclusion Criteria for Metabolically Unhealthy Group: Required: \- Waist circumference: men ≥ 40, women ≥ 35 inches AND ≥ 1 of the following:
- Systolic blood pressure: \> 130 mmHg
- Diastolic blood pressure: \> 85 mmHg
- Fasting glucose: \> 100 mg·dl-1
- Fasting triglycerides: \> 150 mg·dl-1
- HDL: men ≤ 40, women ≤ 50 mg·dl-1
Exclusion criteria
- BMI \<18 or \> 40 kg/m\^2
- potential allergy to Haskap or placebo ingredients
- use of anti-inflammatory, lipid lowering, glucose lowering, blood pressure, or any other medications that may interfere with study measures
- pregnant or lactating woman
- diagnosis with type 1 or type 2 diabetes or any other condition that may interfere with study measures
- smoke cigarettes
- have taken antibiotics in the past 90 days
- take supplements including pre/probiotics or "superfoods" within 30 days of starting the study
- are planning on starting a weight loss or exercise regiment change
- follow a specific diet such as low carbohydrate, vegan, and vegetarian
- consume over 5 servings of fruit/vegetables per day
- are unwilling to reduce caffeine intake to one 8 oz serving per day for the durations of the study
Where
- Bozeman, Montana
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 2, 2025 · Source of record for eligibility and locations